Details for New Drug Application (NDA): 207497
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The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 207497
Tradename: | LAMOTRIGINE |
Applicant: | Amneal Pharms |
Ingredient: | lamotrigine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207497
Mechanism of Action | Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 207497
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 207497 | ANDA | AvKARE | 42291-443 | 42291-443-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-443-30) |
LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 207497 | ANDA | AvKARE | 42291-444 | 42291-444-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-444-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 30, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 30, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 30, 2018 | TE: | AB | RLD: | No |
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